Snapshot of the Opioid Crisis (Legal Cases)

This is blog 6 of 10 blogs in the overdose awareness and overdose prevention series.

International Overdose Awareness Day (31st August) is rapidly approaching. It warrants a discussion of the opioid crisis in the United States, a 20-year phenomenon where over 800,000 people have lost their lives to opioid toxicity thus far. An overview of current opioid crisis legal cases being played out in justice systems across the United States may provide a valuable perspective.

This information reminds pharmaceutical manufacturing organisations of the importance of complying with GMP/GDP regulations, data integrity requirements, and the FDA’s CFRs.

And it reminds ALL of us – as individuals and businesses – to support overdose prevention initiatives such as International Overdose Awareness Day.

Read the blog on 2020-2021 overdose statistics

Download the latest Australian overdose statistics revealed in the Penington Institute’s 2021 Australian Overdose Report.*

*Australian Overdose Report publication date: 31st of August 2021.

Drug-induced deaths: opioids overdose statistics

Some of the 800,000 overdose deaths in America are linked with prescription opioid medications (primarily OxyContin).

These medicines were over-marketed, over-prescribed and over-used. Opioid tolerance would eventually develop, and patients would increase their dosing above recommended amounts.

Increased dosing, and long term use, often led to serious consequences.
These consequences included opioid dependencies, organ damage, disabilities, and death.

Opioid-related overdose deaths also resulted from purchasing contaminated products through illicit supply chains. These deaths were linked with opioid product substitutions (or alternative routes of administration), such as opioid injections vs ingestion (or skin patches).

Opioid prescriptions were also sought from unauthorised online pharmacies; leading to widespread use of substandard, contaminated, counterfeit opioid medications.

Other factors linked with the ongoing opioid overdose epidemic:

companies encouraging physicians to over-prescribe (illicit sales strategies)
diversion of prescription opioids to non-medical supply chains (medication theft/prescription fraud)
patients substituting ‘street drugs’ for prescription medications
- injecting heroin to ease a bio-chemical dependency that developed after using prescription opioids
- attempts to compensate for the expiry of a prescription drug (prescription unavailability)
polysubstance use overdose toxicity (combining opioids with other substances e.g. alcohol, cocaine, MDMA, Ecstasy)
non-medical use of opioids for ‘recreational’ purposes (experimentation or ‘party drugs’)
diversion of opioids/synthetic opioids/starting materials into criminal supply networks (with no quality monitoring systems/traceability)
other dangerous behaviours related to opioid dependencies

Approximately 3 in 4 drug-induced deaths are accidental.

How many opioid overdose deaths were linked with OxyContin, compared to illicit opioids and other drugs?

This figure is somewhat challenging to estimate with accuracy.

One challenging aspect of overdose investigations is that they tend to involve polysubstance use (drug mixing).

However, based on figures from legal proceedings, coroner reports and overdose prevention research:

It is estimated that at least half of the > 800,000 deaths from opioid products were likely linked with prescribed medications (e.g. OxyContin).
These medicines were overprescribed and/or overused by patients, or diverted for non-medical use.

OxyContin was manufactured by Purdue Pharma, a company owned by the Sackler family.

Purdue Pharma’s opioid products were heavily marketed by the McKinsey Group. The McKinsey Group, as well as Purdue Pharma, are currently involved in numerous legal battles in relation to their responsibility/liability for drug-induced deaths linked with illicit sales & marketing strategies.

Watch the <3 minute-long YouTube video describing the overdose epidemic.

Many opioid-linked overdose deaths involved polysubstance use.

Illicit products containing opioids/synthetic opioids also contributed to the overdose epidemic and opioid crisis — as did polysubstance use.

A majority of the 800,000+ deaths involved accidental/unintended overdose toxicity and/or drug-drug interactions.

Synopsis of legal cases involving prescribed opioid products, including OxyContin

Opioid overdose deaths | liability claims in the United States

The US Department of Justice and State District Attorney Offices are currently considering legal cases and settlement proposals in relation to Purdue Pharma and McKinsey.

Liability cases linked to opioid-overdose deaths are currently being decided in various justice systems in the United States, at State and Federal levels.

Purdue Pharma’s proposed settlement amounts for OxyContin deaths/liability claims involve billions of dollars.

Proposed legal case settlements from Purdue Pharma start at approximately $4.5 billion USD but could reach $12 billion USD — or even $20 billion dollars — over time.

Purdue’s proposed bankruptcy terms and payouts — if approved by the courts — will far exceed any previous pharmaceutical product liability cases and settlement amounts, which ranged between $2 and $3 billion USD.

Opioid crisis legal cases are based on liability claims against the manufacturers of these products. Purdue isn’t the only manufacturer being sued. They are, however, considered the largest legal contributor to the opioid epidemic.

An example of the OxyContin liability claims currently moving through US court systems involve:

opioid-product health harms (organ damage/brain damage, accidents)
overdose deaths
failure to warn patients of opioid dependency risks and overdose toxicity risks
fraudulent advertising by manufacturers in the US in relation to the safety of opioid products such as OxyContin
failure to implement effective pharmacovigilance systems / SAE reporting systems
offering physicians incentives to over-prescribe opioid medications [without valid medical reasons and/or without adequate supervision or patient warnings], such as:
– financial incentives
– false claims that opioid medications were ‘safe’ and non-dependency forming
– withholding information from prescribing physicians regarding dependency risks and other product harms
inadequate adverse event reporting systems (Pharmacovigilance compliance breaches)

Opioid pharmaceuticals: legal cases and settlement agreements relate primarily to liability for overdose deaths and/or permanent disability.

Over 100,000 initial legal cases involved one manufacturer – Purdue Pharma – and equated to trillions of dollars in liability.

Source: Reuters

Purdue Pharma is the primary pharmaceutical manufacturer being sued for industry misconduct and overdose deaths; but they are not alone in facing charges.

Legal cases (liability claims) involving opioid medications number into the 100,000’s.

These cases revolve around liability for opioid dependency conditions and overdose deaths.
Some cases against Purdue (and/or their marketing agency) are individual liability cases.
Others are large class action lawsuits and/or bankruptcy settlement cases.
Settlement proposal terms could equate to over $12 billion dollars or more, over time, for a single manufacturer (Purdue Pharma).

But the net cost to the industry could well reach over $26 billion dollars in legal case settlement amounts, according to industry analysts.

The initial lawsuits, prior to settlement cases, saw Purdue Pharma facing legal claims totalling over $2 trillion dollars.

What are the settlement terms for Purdue Pharma’s bankruptcy filing and liability claims?

Payouts will end up being less than the trillions of dollars demanded in initial lawsuits.
But these are unprecedented cases and claims.

Significant legal cases involving Purdue Pharma, the Sackler family, and the McKinsey Consulting Group are being heard (or yet to be settled) at the present time (August 28, 2021).

September through December of 2021 will likely see additional financial settlements in liability cases against Purdue Pharma, the McKinsey Group, and other opioid manufacturing firms; as well as the finalisation of Purdue Pharma’s bankruptcy filing terms/conditions.

Proposed bankruptcy/lawsuit settlement terms will limit (cap) Purdue’s longer-term liability for opioid deaths.
These settlements also hinge on eliminating the liability of 3rd parties associated with overdose claims.
In general, claims involve settlement ranges of $4.5 billion USD to $8 billion USD to up to $12 billion USD over time.

Needless to say, these terms are contentious.

Many Justice Departments, bereaved family members, and other loved ones are dissatisfied with these terms.
Not accepting the proposed settlement terms from Purdue Pharma, however, could prove risky in terms of settlement payouts.
A major legal decision targeted for August 2021 was postponed this week, until at least September.

Read the Reuters article on the postponement of the Purdue Pharma legal decision until [early September 2021], dated 26 August 2021.

District Attorney Offices and Purdue Pharma settlements

Examples of settlements by Purdue Pharma and McKinsey (State District Attorney Offices in the USA)

Read the Texas District Attorney AG Paxton’s settlement with Purdue Pharma’s marketing team, McKinsey – for $38.4 million dollars. (August 2021)
15 US States have already settled with Purdue Pharma (read the New York Times article if you have subscription access) – July 2021
Read the publication by the United States’s Department of Justice regarding criminal charges/criminal case proceedings against the Sackler Family (2020).

Settlement terms and 3rd party liability cases

Purdue Pharma and its executives/board (and owners) are being pursued by numerous US Government agencies/District Attorney offices. So, too, is Purdue’s marketing consultancy firm – the McKinsey Agency. Limitations on future liability claims and 3rd party liability claims are key terms of bankruptcy terms and financial settlement proposals — and precisely why these legal cases are proving difficult to resolve in many jurisdictions.

The important role of quality risk management systems – and how GxP compliance breaches led to the opioid epidemic

Legal cases in relation to overdose deaths are linked with significant breaches of the FDA’s CFRs (FDA regulations), PIC/s GMP regulations, GxP compliance guidelines.

While initially denying responsibility and stating patients and doctors were responsible for the opioid epidemic, Purdue Pharma later admitted responsibility for misconduct. The evidence in court was overwhelming. Purdue Pharma, and their marketing agency (McKinsey), intentionally misled patients and doctors in relation to the potential harms of OxyContin.

The message to manufacturers is clear. Compliance with GMP and the FDA CFRs (or other relevant regulations) is crucial. Non-compliance can lead to disastrous outcomes in terms of patient deaths, legal liabilities, and criminal charges for executives and business owners.

These landmark billion-dollar opioid settlement cases will surely change the regulatory landscape once again.

Examples of Opioid case settlements

What did Purdue Pharma take responsibility for?

Not warning doctors/patients their products were ‘habit forming’
Using incentives to get doctors to over-prescribe OxyContin
Falsely marketing their products as ‘safe’ and downplaying opioid dependency risks
– misleading product information and website content
– inaccurate packaging and labelling
Other misconduct and breaches of cGMP/FDA CFRs

Have the Purdue Pharma opioid epidemic legal cases been settled yet?

Purdue Pharma was forced to file for bankruptcy as cases were being heard in various justice systems.
Some cases have been resolved.
For example, 15 US States reached OxyContin settlements with Purdue Pharma in early July 2021, according to filings in the state of New York.

Settlement terms for other States in the US, and for thousands of other claims, are still being hashed out in the legal system.

Purdue Pharma proposed a multi-billion-dollar settlement claim. But this settlement hinges on limited liability/limited 3rd party liability — or rather, a clear waiver — in relation to future claims. It is an offer that is highly contentious, given the number of deaths related to their product sales/product marketing strategies.

Settlement amounts offered by Purdue Pharma’s legal team are estimated to eventually reach $12 billion USD (and potentially $20 billion USD over time).

But Purdue Pharma is not alone. As an industry, the opioid epidemic will end up costing pharmaceutical manufacturers up to $26 billion USD to settle liability claims.

Why is the proposed Purdue Pharma settlement contentious?

Individuals impacted directly by the overdose deaths that occurred during the last 20 years of the opioid epidemic — and the District Attorney Offices of many states – believe the terms are not satisfactory, given the waiver on liability for future claims/third-party claims.

Additionally, during the opioid crisis, it is reported that Sackler family members “extracted over $10 billion USD [from Purdue Pharma’s income]”.

One recent BBC article indicated the Sackler Family, despite their notable philanthropy, was likely seen as “the most hated family in America right now”.

McKinsey Opioid Settlement reveals [GMP] Compliance Best Practices/requirements

What States in the United States (US) were impacted by opioid-related overdose deaths and over-prescribed medications?

Review the chart, below, excerpted from an article by Douglas C. McDonald, Ph.D.,^* Kenneth Carlson, A.B.,^* and David Izrael, M.S.^*Geographic Variation in Opioid Prescribing in the US.

What types of misconduct were executives at Purdue Pty Ltd and McKinsey accused of (and admitted to doing)?

Pharmaceutical industry regulations require businesses to comply with cGMP guidelines. These include PIC/s Annexes, the FDA’s CFRs, Good Distribution Practice (GDP), Data Integrity (DI) and other regulations that serve to ensure medicines meet quality, safety, and efficacy standards. These regulations aim to keep patients safe and to ensure manufacturers follow ‘good manufacturing practice’ (GMP) responsibilities and quality controls.

Purdue and its marketing agency (McKinsey) admitted to misconduct that relates to breaches of FDA regulations/CFRs — and other laws designed to protect patient/community safety.

inaccurate labelling/packaging
lack of appropriate patient warnings of habit-forming nature of the medications
false advertisements (fraudulent marketing content) which indicated the products were ‘not habit forming’ despite they were opioid-based medications

What did Purdue Pharma admit to in court?

Purdue has accepted responsibility for “enabling the supply of drugs ‘without legitimate medical purpose'” and for other misconduct.

The pharmaceutical manufacturer broke numerous FDA regulations (CFRs) and other laws.
The company’s marketing agency/consultancy firm has also been charged/implicated in these legal suits and is being pursued separately.
In addition to Purdue Pharma lawsuits; the Sackler family members are believed to have been listed as defendants in at least 26 separate legal cases.

Billions of dollars in legal case settlements plus criminal charges

Financial settlement proposals for liability claims against Purdue Pharma (owned by the Sackler family) currently range from $4.5 billion USD to $8 billion USD.
But it could end up costing Purdue Pharma at least $12 billion over time, according to business analysts.
Proposed settlements, however, rest on approval of ‘a shield against future claims/3rd party claims’, and hence, are extremely contentious.

(Source: Financial Times)

Some of the 49 States with legal claims against Purdue Pharma (and/or the McKinsey Group) have now agreed to the proposed bankruptcy/financial settlement terms, including future claim limitations and the protection of 3rd parties. But a number have not done so.

Opioid crisis legal cases and the continuing rise in opioid-related overdose cases

The opioid crisis in the United States is now well-recognised. Over 800,000 people died from opioid-toxicity (opioid overdoses) in the United States in a 20 year period. Opioid crisis legal cases are now being played out in various US State justice systems, with Purdue PTY LTD considered a major contributor to over-prescribed/habit-forming medications. Even with this awareness — and legal cases attempting to hold manufacturers (such as Purdue) and their marketing teams (McKinsey) responsible for these deaths — there was still an increase in prescription opioid overdose deaths as recently as 2017-2019.

How did the opioid crisis evolve?

Narcotics, such as pain medications, are highly controlled medicines.
They can be life-saving medications in terms of Quality of Life (QoL) and Health Quality of Life (HQoL).
For cancer patients, opioids can be the only type of medication that alleviates excruciating pain.

But being highly controlled pharmaceutical products (monitored by the DEA in the US, the EMA in Europe, and the TGA in Australia) doesn’t mean these substances won’t be diverted into criminal supply chains. Nor over-prescribed at times. Nor diverted for non-medical use purposes.

Nor does being a controlled substance mean that opioid prescriptions won’t be overused or misused by patients (or by their loved ones and/or carers).

It is not uncommon that a relative, friend, or care provider diverts a patient’s opioid medications for non-medical use purposes or for diversion into illicit, highly profitable supply chains.

Over the past 2 decades, opioid prescriptions were being overprescribed, overused, and/or diverted into criminal supply chains.

As habit-forming medications, the use of opioids often led to increased dosing over time (well above dosing-safety recommendations) for some patients. It also led to bio-physiological dependencies. And these dependencies sometimes led patients to engage in medicine-substitution efforts, such as using heroin by injection methods.

But a primary component of the opioid epidemic was the intentional misrepresentation of drug-dependency risks and other potential opioid harms, including the illicit, highly aggressive marketing techniques/sales strategies employed by Purdue Pharma, the McKinsey Group. and their colleagues.

These factors convened to form the ‘opioid crisis’ which contributed to an extremely number of overdose deaths (approaching 1 million) as well other opioid-related harms.

The high rates of drug-induced deaths from opioid products (overdoses related to medically-prescribed medicines, non-medical use of opioid-based pain-medications, and illicit opioid supply chains) is known as the “opioid crisis”.

Opioid overdoses involved prescription medications as well as illicit opioid supplies

Opioid overdoses involved prescription medications, diverted medications (stolen by, or given to, individuals without prescriptions) and illicit drug chains intercepting products intended for legitimate manufacturers.

Read how APIs and pharmaceutical products are diverted into illicit supply chains.

As mentioned in previous articles in this 10-part blog series on overdose awareness/overdose prevention, opioid products can be habit-forming.

Patients taking opioid prescriptions should be closely monitored by their medical teams, for adverse reactions such as drug-drug interactions, overdose toxicity, and opioid dependency.
Patients and their loved ones should be made aware of the risks of overdose toxicity from polysubstance use (mixing medications/substances) and excessive dosing.

And everyone should learn what to do in a suspected overdose scenario.

NMU risks and prescription medication overdoses: Purdue Pharma Case Study

Example: OxyContin – Purdue’s Pharma’s guilty plea and bankruptcy settlement proposals

Millions of prescription drug dependencies — and hundreds of thousands of deaths from overdoses (or other opioid-related harms) — have been linked to prescription opioid dependencies and illicit products containing other forms of opioids.

It is believed that drug-related overdose deaths reached epidemic levels in relation to illegally marketed, falsely advertised, and over-prescribed medications.

The opioid epidemic in the United States is far from over, and opioid deaths are continuing to rise.

Lawsuits files in 49 U.S. States estimated the liabilities of Purdue Pharma and/or the Sackler family would equate to trillions — not billions — of dollars.

Lawsuits filed by various States in the US against Purdue Pharma, its executives, and colleagues initially added up to over $2 trillion USD — not billions.

But many of these cases are being settled for far less than that. Even so, Purdue Pharma’s OxyContin settlements will still exceed previous payout amounts in the history of pharmaceutical-industry based lawsuits (for a single manufacturer).

Despite billions of dollars being offered, however, there is widespread concern that the proposed bankruptcy approval conditions will limit future claims and 3rd party liability — leaving future opioid crisis overdose victims and their loved ones without an avenue for justice.

Settlements of McKinsey Group Legal Cases (Purdue Pharma/OxyContin)

The McKinsey Group – the marketing consulting agency for Purdue Pharma — ended up settling a case with 47 states for over $573 million USD.
This was in addition to other lawsuits that weren’t part of that agreement.
As noted above, the Texas District Attorney (Paxton) just attained a settlement figure of $38.4 million USD from McKinsey.

At the centre of the opioid crisis in the United States are opioid-based products.

In particular, the crisis revolved around pain-relieving pharmaceutical products (by the brand name OxyConin), being manufactured and marketed by Purdue Pharma (based in Stamford, Connecticut) and Purdue’s marketing team, the McKinsey Group.

Other pharmaceutical manufacturers were producing similar pain-relieving medications, and a few other key groups are involved in legal settlement cases currently before the courts.

Source: Texas Attorney General (AG Paxton); NIH (National Institute of Drug Abuse)

The Center for Disease Control (CDC) indicates that total deaths from overdoses, since 1999, exceed 800,000 lives lost.

Excerpts:

“In 2019, an average of 38 people died each day from overdoses involving prescription opioids, totalling more than 14,000 deaths.”
“While prescription opioids were involved in over 28% of all opioid overdose deaths in 2019, there was a nearly 7% decrease in prescription opioid-involved death rates from 2018 to 2019.”

Source: CDC report on opioid overdose rates

Recent overdose death statistics and reports

Prescription opioid fatalities (2017-2019 overdose trends analysis)

The opioid epidemic is now well-recognised, but far from over.

There has been a 7% rise in prescription-opioid deaths from 2017-2019, estimated to be about 14,000 per year in 2017.
In 2019, there were a total of over 70,000 deaths due to overdoses in the USA alone.

More needs to be done to monitor use of these medicines and reduce substance dependencies and overdose risks.

CDC opioid use statistics (opioid prescription numbers)

More than 191 million opioid prescriptions were dispensed to American patients in 2017

There are wide variations in opioid prescription rates across [USA] states
Regional variations in the use of prescription opioids cannot be explained by the underlying health status of the population.

Resources / Journal Articles and Recommended further reading

Counterfeit medications – global statistics and public health risks of substandard medications and counterfeit drugs.

Geographic Variation in Opioid Prescribing in the U.S. (2012); Journal: J Pain , Authors Douglas C. McDonald, Ph.D.,^* Kenneth Carlson, A.B.,^* and David Izrael, M.S.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3509148/

Published in final edited form as: J Pain. 2012 Oct; 13(10): 988–996. DOI: 10.1016/j.jpain.2012.07.007

PMCID: PMC3509148 – NIHMSID: NIHMS399782 PMID: 23031398

This is the 6^th of 10 articles/blogs discussing drug overdose statistics and polydrug use harms.

Overdose Awareness and Prevention Resources and Research

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Industry advice

Pharmaceutical manufacturers, pharmacists, and patient care teams must ensure all personnel — including contractors (such as the McKinsey Group) are appropriately trained to comply with regulations including but not limited to:

FDA CFRs for pharmaceutical products
cGMP compliance matters
PIC/s GxP regulations
Good Distribution Practice (GDP)
Data Integrity
Pharmacovigilance systems (SAE/ADE reporting to Regulatory Authorities)
Complaint handling & reporting systems
Other drug-effect safety signals (trends monitoring)
Product-relevant Annexes

For online cGMP training courses, click here.